A major trial is set to begin on Wednesday in Chicago, where four families have filed lawsuits alleging that baby formula manufactured by Abbott Laboratories caused their premature infants to develop a serious bowel disease. The case will be heard in the Cook County Circuit Court and represents the latest development in a growing wave of litigation against formula manufacturers.
The families claim that the company failed to warn healthcare providers about the potential risk associated with its cow’s milk-based formula products designed for premature infants.
Allegations Linked to Necrotizing Enterocolitis
The lawsuits centre on a severe gastrointestinal condition known as Necrotizing Enterocolitis (NEC). This disease causes inflammation and death of bowel tissue and primarily affects premature newborns.
According to the plaintiffs, the infants—born in hospitals in the Chicago area between 2012 and 2019—developed NEC after being fed the company’s specialised formula products. Although the children survived, three required surgery, and all continue to live with long-term health complications.
The trial will consolidate four separate lawsuits into a single case and is expected to continue for several weeks, beginning with jury selection.
Company Denies Claims
Abbott Laboratories has declined to comment on the ongoing trial. However, the company has consistently denied that its formula products cause NEC.
Instead, the manufacturer maintains that these formulas play a critical role in caring for premature infants, particularly in situations where mothers cannot produce enough breast milk. According to the company, such products remain essential components of neonatal care in hospital settings.
Hundreds of Lawsuits Filed Nationwide
As reported by Reuters, the Chicago trial represents only one part of a broader legal battle involving nearly 1,000 lawsuits filed against Abbott Laboratories and Mead Johnson, the manufacturer of Enfamil formula and a subsidiary of Reckitt.
More than 700 of these cases have been consolidated in a federal court in Illinois, while others remain pending in state courts in Illinois, Missouri, and Pennsylvania.
Importantly, the disputed products are specialised hospital formulas and milk fortifiers used for premature infants, rather than the standard infant formulas widely available in retail stores.
Plaintiffs argue that manufacturers failed to warn doctors that premature infants fed formula face a higher risk of NEC compared with babies fed breast milk, donor milk, or human milk–derived formula.
A Serious Disease With Significant Mortality
Necrotizing enterocolitis remains one of the most serious gastrointestinal emergencies in newborns. The disease primarily affects premature infants and carries an estimated mortality rate exceeding 20 percent.
Although many infants survive with treatment, severe cases may require surgery and can lead to lifelong complications, including digestive disorders and developmental issues.
Scientific Debate Over the Cause
Despite the allegations, medical experts and regulatory bodies have debated the underlying causes of NEC.
In 2024, U.S. regulatory agencies and a working group of scientists convened by the National Institutes of Health released a joint report examining the issue. Their findings suggested that the absence of breast milk, rather than exposure to formula, may be associated with the increased incidence of NEC.
The companies involved have also emphasised that clinicians have long recognised the protective benefits of breast milk, but they maintain that formula itself does not cause the disease.
Mixed Outcomes in Previous Trials
So far, the legal outcomes in similar cases have been mixed.
In 2024, a jury in St. Clair County ordered Mead Johnson to pay $60 million to the mother of a premature infant who died after receiving Enfamil formula. Shortly afterward, a jury in St. Louis, Missouri, ordered Abbott Laboratories to pay $495 million in damages in another case. Both verdicts are currently under appeal.
Meanwhile, the American Academy of Pediatrics filed a legal brief supporting Mead Johnson’s appeal, arguing that formula feeding remains part of the standard medical care for premature infants when breast milk is unavailable.
In another Missouri case in October 2024, Abbott and Mead Johnson initially secured a favourable verdict. However, the judge later ordered a new trial after finding that the companies’ lawyers had acted improperly. That decision is also under appeal.
Federal Cases Yet to Reach Trial
Although many lawsuits have been filed in federal court, none have proceeded to trial so far.
The federal judge overseeing the consolidated litigation has dismissed three of the four cases selected as bellwether trials. In the most recent ruling in October, the judge concluded that Abbott had presented substantial evidence demonstrating the medical need for the formula and that the alternative feeding approach proposed by the plaintiffs was not feasible.
As the Chicago trial begins, the outcome may influence the direction of hundreds of similar cases pending across the United States.